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Posted by on Oct 7, 2017 in Non-Hodgkin lymphoma | 0 comments

In a nutshell

This study compared rituximab (Rituxan) and CT-P10 treatments for patients with previously untreated advanced stage follicular lymphoma. The study concluded that CT-P10 is just as safe and effective as name-brand rituximab. 

Some background

Follicular lymphoma (FL) is a type of non-Hodgkin lymphoma. It is commonly treated with the R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone). Rituximab has greatly improved patient outcomes.

The patent on rituximab expired in 2016. Generic, biosimilar (almost exactly the same as the name-brand product) medication is being manufactured for rituximab. CT-P10 is one biosimilar medication. Research must confirm that CT-P10 produces the same outcomes as name-brand rituximab

Methods & findings

140 patients were recruited for this study. All patients had advanced stage (III or IV) FL. 70 patients were randomized to receive CT-P10 plus CVP. 70 patients were randomized to receive rituximab plus CVP. All patients received 375 mg/m2 of either CT-P10 or rituximab on day 1 of a 21-day cycle. Patients received 8 cycles of this regimen.

30% of patients in the CT-P10 group experienced a complete response (no detectable cancer). 22% of patients in the rituximab group experienced a complete response. The overall response rate (patients with complete or partial response) for patients in the CT-P10 group was 97%. The overall response rate for patients in the rituximab group was 92.6%.

Patients in each group had similar numbers of adverse events (any side effect that occurs during treatment). There was no significant difference between adverse events between the CT-P10 group (53%) and the rituximab group (49%). 

The bottom line

The authors concluded that CT-P10 produces similar outcomes and has a similar safety profile to name-brand rituximab, and is a good treatment option for patients with advanced stage follicular lymphoma. 

Published By :

The Lancet. Haematology

Date :

Aug 01, 2017

Original Title :

Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial.

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